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### Evaluation of Enforcement of the Mexican Ban on Feeding Ruminant Proteins to Ruminants July 2009

Summary

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) is proposing to amend its regulations related to bovine spongiform encephalopathy (BSE) to align more closely with recommenda tions of the World Organization for Animal Health (OIE). Under these regulations, APHI S must determine the date of effective

enforcement of a ruminant-to-ruminant feed ba n for any controlled-risk country that wishes to export live cattle to the United States; live cattle exporte d from a controlled-risk country

must have been born after this date. APHIS evaluated information submitted by Mexico and

conducted a site visit and determined that the da te of an effectively enforced feed ban for Mexico is November 30, 2007.

I. Background

APHIS currently prohibits or restricts the importation of live ruminants and ruminant products for BSE based on regulations in title 9 of the Code of Federal Regulations (CFR) §§ 94.18(a)(1), (a)(2), and (a)(3). APHIS allows the importation of such commodities from

countries not listed in those sect ions (assuming no other restricti ons due to other diseases are in place) because a risk from BSE is not evident.

APHIS is proposing to amend the regulations by more closely alig ning them with the 2009 recommendations of the OIE – i.e., BSE code chapter. These changes would apply to the regulations for bovines (cattle and bison of the species Bos indicus, Bos taurus, and Bison

bison ) and bovine products and byproducts. While enhancing international harmonization, these updates do not reflect a change in our level of protection of U.S. livestock from BSE.

The proposed BSE regulations a lign with OIE’s Terrestrial An imal Health Code Chapter 11.6 [1] by (1) adopting the categories and criteria for classification of the BSE risk status of exporting countries, and (2) usi ng those categories to determin e appropriate import policies. In addition, APHIS is proposing regulatory chan ges to recognize the BSE risk status of

countries that have been eval uated and classified by OIE.

Under current regulations, liv e bovines are eligible for importation from Mexico if the conditions in 9 CFR §§ 93.405(a)(3), 93.406, 93.427, a nd related sections are met. Briefly, these conditions specify that live rumina nts meet screwworm, tick, tuberculosis, and brucellosis requirements. In May 2008, the OIE classified Mexico as a BSE controlled-risk region (like the United States and Canada). T hus, under the new regulations that APHIS is proposing, live bovines from Mexico would be s ubject to additional import requirements for BSE. Consistent with OIE recommendations, the importation of live bovines from any BSE controlled-risk region, including Mexico, would be limited to those born after the date of

effective enforcement of a ruminant-to-rumi nant feed ban in the exporting region.2 In determining that a country ha s controlled-risk status for BS E, the OIE concludes that the country has an effectively enforced feed ban in place. However, the OIE does not determine

the date on which the feed ban was effectivel y enforced. That task falls to the importing country. To determine this date for Mexic o, a team of experts from APHIS and the Department of Health and Human Services’ Food and Drug Administration (FDA) evaluated information provided by Mexico’s Ministry of Agriculture, Livestock, Rural Development, Fisheries, and Food (Secretaría de Agricultu ra, Ganadería, Desarrollo Rural, Pesca y Alimentación or SAGARPA), including the dossi er on BSE that Mexico submitted to the OIE in December 2007. The team gathered additi onal evidence during a site visit conducted in August 2008, during which it di rectly evaluated Mexico’s fe ed program as it relates to

BSE.

II. Mexico’s OIE Status for BSE

In December 2007, Mexico submitted to the OIE a dossier containing BSE information to support an overall BSE evaluation and to obt ain a BSE risk classification [2]. The information in the dossier was evaluated by in ternationally recognized BSE experts. On May 27, 2008, the International Committee of the OIE adopted Resolution XXI [3] recognizing Mexico as having a controlled BSE risk in accordance with criteria provided in Chapter 11.6

of the Terrestrial Animal Health Code.

According to the OIE, commodities from countie s with controlled BSE risk designation pose a controlled risk of transmitting the BSE agen t when commodity-specific risk mitigation measures are met. In the case of live bovines, th e primary mitigation is that the animal must

be born after the date from which a ban on feeding meat-and-bone meal (MBM) and greaves derived from ruminants was effectively enforced in that region. This requirement mitigates the likelihood that imported bovine s were exposed to the BSE agent in a region that had or may have had circulating infectivity.

In granting Mexico BSE contro lled-risk status, the OIE de termined that Mexico has

conducted a risk assessment sufficient to meet OI E criteria for identifying the historical and existing BSE risk factors in the region, and: (1) Has demonstrated that appropriate m itigations are being taken to manage all identified risks, but has not taken every m itigation measure for the length of time that would be necessary to qualify as a BSE negligible-risk region (7 or 8 years, depending on the mitigation measure); (2) Has demonstrated BSE surveillance accord ing to BSE risk classification standards and meets the following conditions:

 There has been no case of BSE reported in the region, and:

 The following conditions have been met and continue to be met, but not for at least the past 7 years: a. The region has conducted an ongoing awareness program for veterinarians, farmers, and workers involved in tran sportation, marketing, and slaughter of bovines to encourage reporting of all bovine s showing clinical signs that could be indicative of BSE;3 b. The region has required notification a nd investigation of all bovines showing clinical signs consistent with BSE; c. The region has carried out the examin ation, in accordance with internationally accepted diagnostic tests and procedures and in approved laboratories, of

brain or other tissues collected as part of the required surveillance and monitoring system; and d. The feeding to ruminants of MBM a nd greaves derived from ruminants is prohibited and effectively enforced in the region, but it cannot be demonstrated through an appropriate le vel of control and audit that the prohibited materials have not been fed to ruminants for at least the past 8

years.

In its review of Mexico’s do ssier, the OIE ad hoc committee concluded that although Mexico qualified as a controlled risk coun try, the risk of recycling and release of the BSE agent is considered to be negligible because specified risk materials 1 (SRMs) are marketed profitably in Mexico exclusively for human consumption. This conclusion is based on data submitted by Mexico which states that brai n and spinal cord from 100 per cent of slaughter ed cattle that meet suitability characteristics are used fo r human consumption and therefore are not

available to be rendered for use in animal feed. Moreover, a review of Mexico’s import history does not indicate a high likelihood of release of infectiv ity in animals or commodities imported from trading partners.

III. Mexico’s Feed Ban

A. Legal Authority

The overarching law concerning animal health in Mexico is the Fe deral Law of Animal

Health. Article 4 of this law gives SAGARPA the authority to promote, encourage, organize, supervise, coordinate, and execute all types of activities pertaining to animal health in which different organizations and agen cies of the municipal, State, and Federal governments, as well as people with a legal interest, can participate.

1. Federal Veterinary Authority

SAGARPA is the Federal department within the government of Mexico responsible for regulating the agriculture and livestock sectors. It is c onsidered equivalent to the USDA. SAGARPA has a delegation (office) in each of the 32 States of Mexico and one in the Lagunera Region 2

.

Within SAGARPA, the National Service of H ealth, Safety, and Quality Agrofood (Servicio Nacional de Sanidad, Inocuidad y Calidad Agroa limentaria or SENASICA) is equivalent to

APHIS. SENASICA is divided into several general divisions (f igure 1), three of which are

1 OIE defines specified risk material s as brain, eyes, and spinal cord.

2 The Lagunera Region consists of five municipalities of the State of Coahuila and ten municipalities of the State of Durango.4 directly focused on animal health: the Animal Health General Director ate (Direccion General de Salud Animal or DGSA), the Animal a nd Plant Health Inspection Service General Directorate (Direccion General de Inspeccion Fi tozoosanitaria or DGIF), and the Agrofood Safety and Quality Control General Directorate (Direccion General de Inocuidad y Calidad Agroalimentaria or DGICA).

Figure 1. Functional organization of SAGARPA

The DGSA is headed by the Chief Veterinary Officer of Mexico. Within DGSA, the Directorate of Import, Export, Animal, and Animal Products Services and Certification (Dirección de Importación, Exportación, Servicio s y Certificación Pecuaria or DIESCP) is responsible for the following:

 Issuing import and export permits for animals and animal products

 Registration and regulation of veterina ry products (chemical, pharmaceutical, biological and feed products)

 Approval of animal disease diagnostic test s and product quality control laboratories;

accreditation of veterinarian s in certain disciplines (laboratory diagnostics; ruminant, poultry, and swine veterinary practice)

 Animal and animal product movement; slaughterhouses

 Issuing health certificates necessary fo r movement of animals and/or animal products within Mexico5 The DIESCP is divided into two subdirectorate s: the Subdirectorate of Imports and Exports and the Subdirectorate of Approval, Certificatio n, Registries, and Servic es (SCRS). The latter is responsible for the evaluation of compliance with the ruminant feed ban. The SCRS is further divided into three departments: (1) the Department of Regul ation and Control of Veterinary Products, Units, and Organisms; (2) the Department of Regulation and Registration of Veterinary Products; and (3) the Department of Regulation of Establishments.

2. State Animal Health Infrastructure

SAGARPA’s 33 State delegations (offices) mana ge the enforcement of Federal regulations and animal health activities at the field level, such as local prevention and control measures, census information, eradication, emergency actions, sampling, prem ises identification, movement controls, and recordkeeping. Each Stat e delegation is headed by a State delegate who has an animal and plant subdelegate.

In Mexico, much of the field work for SAGAR PA’s animal health act ivities is provided through each State’s Committee for the Prom otion and Protection of Animal Production (Comité Estatal de Fomento y Protección Pecuar ia or CFPP), which receives funding from the State government, the livestock industr ies in the State, and the SAGARPA State Delegation. Each of these partie s contributes a third of the budget required for supporting the yearly sanitary activities.

The annual budget and program of activities of the CFPP is approved by SAGARPA. The

CFPP has a President who is selected from one of the livestock industries of that State (bovine, porcine, poultry), a Federal Executiv e Assistant who is the ranking Federal SAGARPA official (State delega te), and a State Executive Assistant who is designated by the State government. The CFPP supports all of S AGARPA’s animal hea lth activities through the hiring of professionals w ho will take samples, conduct censuses of animal populations, and inspect at control check points for movement of animals and animal products. CFPP reports its activities to the SAGARPA delegation.

B. Mexican Feed Regulations

The Official Standards of Mexico (Norma s Oficiales Mexicanas or NOMs) are the regulations governing animal hea lth activities. The mandatory participation of producers in

animal health is based on these NOMs. The NOMs regarding feed and implementation of the feed ban are the following: NOM-012-ZOO-1993 (NOM-012) NOM-025-ZOO-1995 (NOM-025) NOM-026-ZOO-1994 (NOM-026) NOM-060-ZOO-1999 (NOM-060) NOM-061-ZOO-1999 (NOM-061)

NOM 012, NOM 025, and NOM 026 established specifications for the production and quality control of chemical, pharmacological, biological, and nutritional products for use in6 or consumption by animals, as well as th e minimum infrastructure specifications for establishments producing nut ritional animal products.

NOM 061, published in October 2000, prohibited the use of ru minant-origin MBM in feed for ruminant animals. In addition, this regula tion contained a number of other provisions, such as requirements for verifying guaranteed analyses of feeds and for statements on ingredient labels.

NOM 060, published in June 2001, expanded BSE -related feed protections by placing new requirements on rendering operations. NOM 060 specified that rendering plants must establish certain time, temperat ure, and humidity standards fo r processing; maintain receipt, processing, and distribution records; and identify themselves as either type 1 renderers ( who handle mainly materials containing nonruminan t tissues as well as hides and ruminant byproducts obtained from tanneri es) or type 2 renderers (w ho handle ruminant materials containing ruminant tissues )T he regulation prohibited feed ing ruminants with ruminantorigin MBM and required that type 1 rendering plan ts must have control procedures in place.

C. Feed Ban Oversight

The Animal and Plant Health Federal Law of 1974 (published in December 1974) instructed SAGARPA to register all the Mexican compan ies that manufactured and commercialized biologics, pharmaceuticals, and feed products fo r animal use. The law and additional related regulations (Reglamento published in June 1978) also mandated the registration, licensing, and compliance requirements for the final product s. Additionally, the la w required that most of the regulatory oversight of the animal feed industries was to be handled by a SAGARPAcertified veterinarian that ever y firm must employ as a consu ltant for the annual renewal of company registration and product licenses. In 1993, the Federal Law was modified by including additional requirements and mandated that all official requirements were authorized through the NOM, such as the following:

 NOM 012: Regulates final products

 NOM 025: Regulates producers and comme rcial companies that manufactured pharmaceutical and biological products

 NOM 026: Regulates producers and comme rcial companies of feed products

NOMs 012, 025, and 026 required that each company hi re an approved veterinarian (certified by SAGARPA) to handle the regulatory oversight of the sanitary activities, including visits for verification. The registration renewal for each facility include d an official site visit by SAGARPA’s delegations in the Mexican States . In addition, the Animal and Plant Health

Federal Law was modified to include a new Mexican Accreditation Bo dy (Entidad Mexicana de Acreditacion or EMA) to provide support for the verification and certif ication processes.

In 1996, due to the increasing number of comp anies registered and products licensed, new controls were implemented. Accredited vete rinarians were authorized by SAGARPA to perform verification activities on behalf of SAGARPA, in lieu of official personnel. Companies had only to present a letter to SAGARPA from an accredited veterinarian indicating compliance with sanitary requirements.7 Upon publication of BSE-related feed re gulations NOM 061 in 2000 and NOM 060 in 2001,

the verification unit veterinarians became res ponsible for bringing f eed mills and rendering plants into compliance with these regulations. The Department of Regulation and Control of Products and Companies (DRPC) became respons ible for registering and controlling the rendering plants that manufactur e meals of animal origin.

In 2003, the DRPC implemented an inspection pr ogram for all rendering plants to check for compliance with NOM 060. In the same year, th e Mexican Association of Rendering Plants provided support to the process by providing the DRPC with a list of operational rendering plants.

SAGARPA sent official letters to the rendering plants informing them of the need to comply with NOM 060 [4] and organized a workshop to educate veterinarians about the importance of the feed ban regulation and the procedure fo r verifying that feed manufacturers comply with the regulation. By November 2003, the as signments regarding f eed controls were prepared and sent to the St ates. In July and September 2004, SAGARPA State Delegations started verifying the newly registered renderi ng plants. That year, a total of 13 rendering plants were registered in compliance with NOM 060. Three of those were classified as type 1 plants and ten were classi fied as type 2 plants.

In 2005, SAGARPA again sent official letters to the State Delegates asking for their support to find rendering plants that had not yet reported their operation and classification or that had not renewed their annual license. That year, 12 new rendering plants we re registered, 1 as type 1 and 11 as type 2. Additionally, the 13 plan ts registered in 2004 we re revisited to renew their license, bringing the total to 25 licensed re ndering plants. Since 2005, the list of newly licensed and renewed rendering plants ha s been published and updated monthly on SENASICA’s Web site [5].

During 2006, SAGARPA registered a total of 11 new rendering plants; 5 of them were classified as type 1 and 6 as type 2, bringing the number of ve rified rendering plants to 36 by the end of 2006. The same year, SAGARPA reque sted that the EMA provide support for the annual verification of the rendering companie s, and by the end of 2007 EMA verified 100 percent of the rendering companies. These veri fications were independent of those done by

SAGARPA.

In 2007, the structure of the DIESCP was modifi ed and a new subdirectorate was created: the Subdirectorate of Approval, Certification, a nd Registration Services (SCRS). Within the SCRS, the DRPC was divided into three Departments: (1) the Department of Regulation and Control of Veterinary Products, Units and Orga nisms; (2) the Department of Regulation and Registration of Veterinary Products; and (3) the Department of Regulation of Establishments.

The activities of the Department of Regulation of Establishments include the following:

 Registration of companies that manuf acture and/or commercialize biologic, pharmaceutical, and feed products according to NOM 025 and NOM 026

 Coordination of the verification of the establishment inspection program8  Evaluation of compliance with a rumina nt feed ban (NOM 061 and NOM 060)

 Verification of compliance with NOM 061 and NOM 060 label requirements.

According to SAGARPA official s, this reorganization greatl y enhanced the Department’s

contact with various elements of the rumina nt livestock and feed industries and improved SAGARPA’s ability to ensure compliance with th e feed ban regulations that are in place.

During 2007, SAGARPA registered a total of 16 new rendering plants, 7 of which were classified as type 1 and 9 as type 2. At the end of 2007, a tota l of 52 plants were verified.

SAGARPA trained new veterina ry officials to conduct veri fications and collect the documentation needed to complete Mexico’s OIE dossier.

In 2008, SAGARPA registered three type 1 and th ree type 2 rendering plants. At that time, it also started identifying companies that were no longer in operation. As of October 30, 2008, 65 rendering plants were registered and in operation, 20 of them type 1 and 45 type 2.

D. Enforcement and Compliance

SAGARPA and other recognized entities, such as third-pa rty groups (referred to as Authorized Specialists and Verification Units certified by EMA), are authorized by the Federal Law of Animal Health to perform the verification of feed mills. However, only SAGARPA’s Department of Regulation of Es tablishments is authorized to conduct

verification audits at renderi ng plants. SAGARPA enforces the feed ban at rendering plants

and feed mills as follows:

1. Rendering plants

Feed ban enforcement became an increasing pr iority for SAGARPA in 2003 after BSE cases were reported in Canada and the United States. Beginning in 2004, SAGARPA began registering individual rendering plants. As part of the process, the agency established a verification program for Mexican rendering plants to furthe r strengthen oversight and enforcement of the NOMs. SAGARPA’s Depart ment of Regulation of Establishments coordinated the verification program to ensu re that each firm complies with NOM 061 and NOM 060. Each year, the rendering plants must renew their registrati on and must also be included in the list of registered rendering plants, which is published on SENASICA’s Web page and updated monthly [6].

From 2004 through 2007, SAGARPA directed its State offices (delegations) to inspect, on an annual basis, rendering firms that had notif ied SAGARPA that they were operating or previously registered. Incentiv e to provide notice of operation to SAGARPA came mainly

from feed manufacturers who wanted to obt ain source material only from registered rendering plants.

Inspections of rendering plan ts found a very high level of compliance. In 2007, SAGARPA reported two minor infractions in two rendering plants locate d in Yucatán and Guanajuato. The infractions consisted of inadequate docum entation describing the species used in the9 source material for the rendered product [7]. Both establishments were subsequently reinspected and found to be in compliance.

2. Feed mills

SAGARPA began registering f eed mills in 1993. In addition to the routine oversight provided by veterinary consultants, a feed mill inspection program was initiated in 2004. Under this program, the veterinary consu ltants conducted inspectio ns using inspection checklists [8] to verify that feed mills were operating in compliance with NOM 061.

Similar to its oversight of rendering pl ants, in 2005 SAGARPA began applying its verification and registration progr am to all firms involved in th e manufacturing of chemicals, pharmaceuticals, biologics, and feed products fo r animal use or animal consumption. All companies involved in the manufacture, import, and distribution of veterinary products were also required to be registered and insp ected. As of the end of 2008, approximately 2,300 establishments were registered [8]; of thes e, about 500 manufacture animal feeds or feed ingredients, with approximately 200 feed mills producing finished feed for ruminant and nonruminant animals [8].

IV. Livestock Industry and Husbandry Practices

In addition to evaluating Mexico’s legal author ities and their enforcement of the ruminant feed ban, the APHIS–FDA team also sought to understand their significance in the context of the country’s agricultural and so cial practices. Much of this information was obtained from the dossier submitted to the OIE by SAGARPA [2]

In 2008, Mexico’s total cattle inventory was estim ated at 35 million animals, the majority of which is for beef production. Mexico exports approximately 1.1 million head annually, mostly to the United States. The total number of cattle consigned annually in Mexico for domestic slaughter is around 6.7 million head, and the calf crop is estimated at 8.2 million head. The beginning beef cow inventory in 200 8 was estimated at 11.9 million head and the beginning stock of dairy cows was estimated at 2.5 million head. The Mexican domestic cattle inventories for 2009 are expected to increas e due to reductions in cattle exports to the United States and the higher prices of red m eat in Mexico. Cattle slaughter figures for 2009 are forecast to increase at approximately the same rate as in 2008 (2 percent) because increasing feed costs are forcing feedlo t operators to reduc e inventories [9].

As described in SAGARPA’s dossier to the OIE, most Mexican cattle are raised on either dairy farms or beef cattle operations. The national dairy herd is divided into several different and distinct sectors: specialized or technically deve loped dairies, approx imately 17 percent of operations; semi-specialized, 15 percent; double purpose (for beef and milk), 60 percent; and family or backyard units, 8 percent. Both purebred and mixed breed cattle can be found within any of the categories. Dairy production unit s operate either as separate entities or as groups of producers such as Lala or Alpura, which pool the dairy production of many producers in the Lagunera Region and in the Al tiplano of the Mexican Republic. Typically, a10 single feed mill distributes balanced feed to each of the respective group’s members. Feed mills serving the dairy sector largely discontinued the use of rendered animal proteins before

2004.

For beef cattle, Mexico’s production model does not differ greatly from what is done in the United States. Typically, cattle either graze or are fed in confinement, although some producers may use parts of both production models. Operations that primarily graze (such as cow-calf operations) usually provide some supple mental feed, such as salt or minerals. Cattle fed in confinement (e.g., in feed lots) are usually fed a mixed, ba lanced feed. The average age and weight at slaughter varies according to rearing system. Slaughter tends to occur at approximately 3 years on extensive pasture, 2 years on semi-intensive, 1.3 years on intensive fattening, 6 to 7 years for dairy cows, and 10 y ears for breeding beef cows [10]. The review team visited two feedlots, one in the State of Aguascalientes that handles approximately 2000

animals at a time and the other in the Stat e of Querato that handles approximately 5500

animals at a time. On these a nd other feedlots in Mexico, fa ttening typically occurs over a period of 90 to 100 days. The ration fed by the feedlots may contain a wide variety of ingredients, which are prim arily of plant origin.

The nutritional requirements of dairy and beef cattle differ, and the nutritional needs of each vary by age and stage of production. Animal-source proteins may be useful in the rations of dairy cattle to balance specific nutrients (such as lysine and other amino acids, calcium, and phosphorus) and supplement protein intake. However, a variety of plant proteins and animal protein alternatives from nonprohibited sources are available to Mexican producers including processed corn, sorghum, oats, soy products, fi sh meal, porcine blood meal, and feather meal. Furthermore, brain and spinal cord from slaught ered cattle are unlikely to end up in animal feed because they are marketed profitably for human consumption.

V. Rendering and Feed Industries

Globally, the rendering industry pl ays an important role in the risk of recycling BSE infectivity. Although the inclusion of rendered ruminant protein into bovine feed is thought to have caused the initial emergence and amp lification of BSE, th e rendering process can also mitigate the likelihood of further spread or amplification. First, rendering processes can, to varying extents, reduce infectivity of the BSE agent. Second, rendering may also serve as an additional opportunity for the redirection of ruminant protein away from cattle feeds. Such redirection can also be performed by the feed industry. To provide context for these potential sources of risk mitigation beyond that required by regulation, in this section we describe

some characteristics of the Mexican rende ring and feed manufact uring industries.

1. The Rendering Industry

As explain ealier, in Mexico, re ndering plants are classified in to two types: type 1 rendering plants, which process and handle materials fr om pigs, horses, poultry or other nonruminant species as well as hides and ruminant byproducts obtained from tanneries (or their mixture) 3

,

3 Ruminant hides and ruminant byproducts of tann eries are not considered to pose a BSE risk.11 and type 2 rendering plants, which handle ruminant materials or any ruminant tissues that are mixed with tissues of pigs, horses, or other avian species, as well as hides and ruminant byproducts from tanneries (or their mixture) [2, 11].

Rendering plants are also categorized as capti ve (integrated) and non captive (independent), depending on their source of raw materials. Ca ptive rendering plants receive raw material from slaughter or other processing facilities, generally within the same company. This type of enterprise processes raw materials that have been in spected by Federal or State veterinarians. Cattle slaughtered in the aff iliated slaughterhouses can be sourced from livestock production units located far away from the slaughterhouse, or even in other States, depending on market fluctuations and commerce. In general, poultry facilities usually have their own rendering plants. Othe r specialized rendering plants process tannery or leather byproducts; these are usually located w ith shoe industry manufacturers.

Noncaptive (independent) rendering plants co llect raw materials from slaughterhouses and other businesses (such as butcher shops, restau rants, institutions, supermarkets, and other places where meat is processed) that do not have their own rendering facilities. Collected materials include animal fat, bones, hooves, and horns. In addition, some noncaptive rendering plants may render animals that died on-farm or were condemned in slaughterhouses.

The largest numbers of rendering pl ants are located in the States of Mexico and Jalisco, while other States average two plants each [2]. Most of the raw materials used in rendering plants originate from slaughterhouses, p ackers, or butchers. The majority of type 2 plants process bone and uncooked tallow; very little nervous ti ssue (brain and spinal cord) is processed since it is profitably sold fo r human consumption [2, 7, 12]. Ninety per cent of the raw

materials are derived from cattle while the rest comes mainly from swine; poultry and horse materials are rarely rendered. Ovin e material is not used [2, 11].

Animals (particularly range cattle ) that die on the farm usually are not sent for rendering but remain on the farm for disposal. In addition, inst ead of being disposed of, some animals that are ill can be slaughtered on an emergenc y basis on the farm and used for human consumption. Range cattle mortality varies between 2 to 3 percent in most areas of Mexico. The main causes of mortality in range cattle are plant intoxication, an aplasmosis, pneumonia, and rabies. Dead animals may remain in the pastures until they ar e eaten by buzzards and other scavengers, or they may be buried if they are very cl ose to a community or a house. Disposing of dead cattle on the farm is common in the States of Colima, Baja California Sur, and Guerrero; in the Southeast region (the Hu asteca that comprises some municipalities of the State Veracruz, Tamaulipas, San Luis Potosi, and Hidalgo); and in th e desert zone of the North of the country such as Sinaloa, Zacatecas, Sonora, Chihuahua, Nuevo Leon, and

Coahuila.

In dairy cattle production zones with a high density of animals (such as those shared by the State of Aguascalientes and Ja lisco in Altos Region, Tizayuca, Hidalgo; Rincón de Romos, Queretaro; Zumpango, Estado de Mexico; Delicias and Cd. Cu ahtemoc, Chihuahua; Mexicali in Baja California and the Lagunera Region in the States of Coahuila and Durango),12 mortality ranges between 2 and 5 percent annuall y. Deaths are primarily due to intoxication, metabolic disease, pneumonia, reproductive proble ms, and tuberculosis. Dead dairy cattle are rarely rendered and instead are buried, incinerated, or slaughtered under emergency inspection for human consumption.

Most rendering plants in Mexico use the ba tch cooker rendering system consisting of a horizontal vapor cooker with a st irrer. Such systems operate under atmospheric pressure. The cooked batch follows a repetitive cycle where a cooker is loaded with the appropriate amount of raw material then cooked under specific, co ntrolled conditions. Each batch contains from 3,000 to 4,000 kg of raw material that has been ground to a 2.5-cm particle size. Cooking temperatures range from 80 to 160°C, with an average of 120°C. Processing times range from 15 minutes to 8 hours, with an average of 2.5 hours [2].

Experimental studies performed on similar systems elsewhere have shown that batch rendering leads to a greater th an 3 log reduction in BSE infectivity [13, 14]. A smaller number of Mexican type 2 renderers use a c ontinuous system. These systems typically reduce BSE infectivity by 1 to 2 logs, depending on whet her fat is added duri ng the process [13, 14].

At the time of Mexico’s submission to th e OIE, there were 57 SENASICA-registered rendering plants, of which 19 were classified as t ype 1 and 38 were classified as type 2. As of October 2008, these numbers increased to 65 re gistered rendering plants, of which 20 are type 1 and 45 are type 2 [7].

2. The Feed Industry

Mexico is ranked among the la rgest producers of balanced fe ed in the world. Domestic producers dominate the Mexican balanced feed market. The 2008 total production of compound feed (mixed feed manufactured by combining multiple ingredients) was estimated at 26.2 million metric tons (MT), approxima tely 16.6 million MT produced by integrated

firms 4 and 9.6 million MT by commercial manufacturers.

Most of the raw material used for producing prepared feed is of plant origin. Vitamins, minerals, and oils make up most of the rest of the ingredients. Common protein meals contain, among other products, soy meal, feathe r meal, blood, and MBM from various animal species [2, 11].

The site visit review team visited several feed manufacturing facili ties, including large, small, integrated, and commercia l facilities. Most of these firms produced feed for all major pet food and livestock species and, as stated above, most use prin cipally plant origin material (corn, sorghum, oat, soy, etc.). Most companie s either do not use animal protein or only use fish or equine meals. Most of the firms us ed their own trucks fo r making deliveries and occasionally for hauling incoming ingredients. At the facilities visited, the team observed that procedures were in place to ensure proper cl eaning between shipments. Regardless of firm

4 Integrated firms produce their own feed for animals that they typically breed, raise, and slaughter; they also market the resulting meat.13 size, most feed was bagged prior to delivery, w ith only a small amount of feed distributed in

bulk.

The site visit team observed that, in general, the feed manufacturing sector in Mexico has access to the same manufacturing technologies and ingredients that are used by feed

manufacturers in the United States. The t eam found that feed mill management and production personnel were trained in animal nut rition and feed manufacturing. Given that the cattle, swine, and poultry produc tion sectors follow production mode ls very similar to those used in the United States, the feed manufacturin g and distribution system is comparable to the U.S. model. However, the team observed a few differences: (1) farms and ranches tend to have smaller numbers of animals than operations in the United States; (2) feed manufacturers in Mexico tend to use flat storage (storage in piles inside, on the fl oor of a warehouse) for ingredients more commonly than in the United States, where bin storage is more common; and (3) most commercial feed in Mexico is ba gged prior to distributi on and not stored or transported in bulk. The fact that most feed is bagged suggests a lower risk of crosscontamination of equipment with prohibited ma terial during transport and on-farm storage. Moreover, the storage of materials on the wa rehouse floor can allow more thorough cleaning between batches than can typically be performed for bins.

Conclusion: Date of Effective Enforcement of Feed Ban

In May 2008, the OIE announced that it had cate gorized Mexico’s BSE status as controlled risk, based on the committee’s recommendation. This decision was based on several factors, including the level of surveilla nce, the absence of detected cases, and the demonstration “through an appropriate level of control and audit that neith er meat and bone meal nor greaves derived from ruminants has been fe d to ruminants” [12]. Therefore, the OIE determined that Mexico has an effectively en forced feed ban that prohibits the use of ruminant-origin MBM and greaves in feed for ruminants. Proposed changes to regulations would allow APHIS to recognize Mexico ’s controlled BSE risk status.

In determining that a country has a controlled BSE risk stat us, the OIE concludes that the country has an effectively enforced feed ba n in place but does not determine the date on which the feed ban was effectively enforced. Fo r Mexico, APHIS determined that date using information provided by Mexico and corroborated by the site visit team. The information relates to the underlying regulati ons and evidence of their enforcement as well as to the context provided by Mexico’s cultural practices, animal husbandry, and the feed and rendering industries.

We report above in Section III that Mexico ins tituted regulations regarding a ruminant feed ban in 2000 and 2001. NOM 061, published in 2000, prohibited the use of ruminant-origin MBM in feed for ruminants. NOM 060, publis hed in 2001, placed specific requirements related to BSE on rendering plants.

Initially, compliance with these regulati ons was enforced by SAGARPA-certified

verification unit veterinarians em ployed by rendering plants and fe ed mills. In the following years, Mexico continued to enhance the implem entation and enforcement of its feed ban. The14 most recent enhancement was the reorganiza tion of the DRPC and the creation of the Department of Regulation of Establishments . This reorganization and the support from Mexico’s accreditation body for verifying re ndering plants provided additional opportunities

to monitor and enforce the ruminant feed ban.

In addition to information regarding Mexico’s le gal requirements for a ruminant feed ban and their enforcement, the review team also c onsidered Mexico’s cultural and agricultural practices. Practices such as the consumption of SRMs by humans, use of the batch method of rendering, domestic production of feed, and baggi ng of feed act individua lly and in concert to reduce the likelihood of any BSE infectivity circulating in the ruminant population. Therefore, while an effectively enforced feed ban is still necessar y, its importance to the

actual BSE risk in Mexico is less than that for other controlled risk c ountry that has a history of BSE or does not demonstrate these mitigating practices.

As described above, the level of enforcement of Mexico’s ruminant f eed ban has increased over time. The date when the feed ban became effectively enforced is difficult to determine precisely, especially given the low BSE risk background in which the regulations are applied. However, APHIS considers that by the time Mexico prepared and submitted its dossier to the OIE (in December 2007), SAGARPA was able to demonstrate through an appropriate level of control and audit that neither MBM nor greav es were fed to ruminants. Therefore, APHIS is establishing the effective date as November 30, 2007.

While this date of effective enforcement is based on the evidence provided to the OIE by Mexico and gathered during th e site visit conducted by APHIS and FDA, it does not reflect the relative BSE risk of live animals imported in to the United States from Mexico. Rather, it is one step in aligning APHIS’ proposed BSE regulation with OIE guidelines. As stated above, based on Mexico’s import history a nd production and consumption practices, Mexico’s cattle have consistently had an acceptably low risk of exposure to BSE.

References

1. OIE. Terrestrial Animal Health Code, Ch apter 11.6. Available at http://www.oie.int/eng/ normes/mcode/en_chapitre_1.11.6.htm#rubri que_encephalopathie_spongiforme_bovine.
2. SAGARPA. Recognition of the Sanitary Situ ation of Mexico with Respect to Bovine Spongiform Encephalopathy (BSE): Request. 2007.
3. OIE. Final Report of the 76th General Se ssion of the OIE, 25–30 May 2008. Available at http://www.oie.int/downl d/SG/2008/A_RF_2008_webpub.pdf.
4. SAGARPA. Example of official letters sent to rendering plants informing them of the need to comply with NOM 060. 2003.
5. SENASICA. http://148.243.71.63/default.asp?id=916.

6. SAGARPA. Additional inform ation requested by APHIS. 2008.
7. SAGARPA. Documentation regarding re ndering plant infractions in 2007. 2007.

8. SAGARPA. Checklist used to evaluate compliance with feed regulations.15 9. USDA Foreign Agriculture Service. Globa l Agriculture Information Network (GAIN)

Mexico Livestock and Produc ts Annual Report. 2008
10. European Food Safety Authority. Scientif ic Report of the European Food Safety Authority on the Assessment of the Geogr aphical BSE Risk of Mexico (July 2004). Available at http://www.efsa .europa.eu/EFSA/efsa_locale1178620753812_1211902594133.htm

11. SAGARPA. Mexican Enforcement of the Feed Ban. 2007.
12. OIE. OIE Ad Hoc Group for the Evaluation of Country Status for Bovine Spongiform Encephalopathy in Accordance with the Te rrestrial Animal Health Code, p. 44-46. February 2008.
13. Taylor DM, Woodgate SJ, Fleetwood AJ, and Cawthorne RJG. Effect of rendering procedures on the scrapie agent. 1997. Vet Rec 141 (25): p. 643-649.
14. Taylor DM, Woodgate S, Atkinson MJ. Inactivation of the bovine spongiform encephalopathy agent by rendering procedures. 1995. Vet Rec 137 (24): p. 605-10.